510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844962Substantially Equivalent

Emit Qst Acetaminophen Assay

Syva Co., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844962 is the FDA 510(k) clearance record for EMIT QST ACETAMINOPHEN ASSAY, a class II device, cleared for Syva Co. on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 140 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K844962.

Clearance record

Decision date
Received
(25 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva Co. 900 Arastradero Rd., Palo Alto CA
Third party review
No

Clearances, product code LDP

Trailing 12 months
1 clearance under product code LDP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260